U.S. patent application number 16/475916 was filed with the patent office on 2021-05-20 for differential contrast wound filler.
The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Christopher Brian LOCKE, Timothy Mark ROBINSON.
Application Number | 20210146020 16/475916 |
Document ID | / |
Family ID | 1000005403155 |
Filed Date | 2021-05-20 |
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United States Patent
Application |
20210146020 |
Kind Code |
A1 |
LOCKE; Christopher Brian ;
et al. |
May 20, 2021 |
DIFFERENTIAL CONTRAST WOUND FILLER
Abstract
A tissue interface having visually contrasting portions, systems
for using the same, and methods of manufacturing the same are
provided. The wound filler includes a first portion having a first
color and a second portion having a second color. The second color
contrasts to the first color. The first color and the second color
both contrast to red and purple. The first color and the second
color are complementary.
Inventors: |
LOCKE; Christopher Brian;
(Bournemouth, GB) ; ROBINSON; Timothy Mark;
(Shillingstone, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KCI Licensing, Inc. |
San Antonio |
TX |
US |
|
|
Family ID: |
1000005403155 |
Appl. No.: |
16/475916 |
Filed: |
February 21, 2018 |
PCT Filed: |
February 21, 2018 |
PCT NO: |
PCT/US2018/019008 |
371 Date: |
July 3, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62461603 |
Feb 21, 2017 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2207/10 20130101;
A61M 1/90 20210501; A61L 15/56 20130101; A61L 2300/442
20130101 |
International
Class: |
A61M 1/00 20060101
A61M001/00; A61L 15/56 20060101 A61L015/56 |
Claims
1. A wound filler comprising: a first portion having a first color;
a second portion having a second color, the second color having a
contrast to the first color; and the first color and the second
color having a contrast to red and purple.
2. The wound filler of claim 1, further comprising a third portion
having a third color, the third color having a contrast to both the
first color and the second color.
3. The wound filler of claim 1 or 2, wherein the first color is
white.
4. The wound filler of any of claims 1-3, wherein the second color
is black.
5. The wound filler of any of claims 1-3, wherein the first color
is white and the second color is black.
6. The wound filler of any of claims 1-5, wherein: the first
portion has a first pattern; and the second portion has a second
pattern.
7. The wound filler of claim 6, wherein the first pattern comprises
stripes, and the second pattern comprises corresponding
stripes.
8. The wound filler of claim 7, wherein the stripes of the first
pattern and the second pattern have a width between about 2 mm and
about 10 mm.
9. The wound filler of either of claim 7 or 8, wherein: the stripes
of the first pattern have a first width; the stripes of the second
pattern have a second width; and the first width is different from
the second width.
10. The wound filler of either of claim 7 or 8, wherein: the
stripes of the first pattern have a first width; the stripes of the
second pattern have a second width; and the first width is the same
as the second width.
11. The wound filler of claim 6, wherein the first pattern
comprises first rings, and the second pattern comprises second
rings.
12. The wound filler of claim 11, wherein the second rings are
concentric with the first rings.
13. The wound filler of claim 6, wherein: the first pattern
comprises bands having a narrow end proximate to a center of the
wound filler and a second end having a wide end proximate to an
edge of the wound filler, the wide end having a width greater than
the narrow end; the second pattern comprises bands having a narrow
end proximate to a center of the wound filler and a second end
having a wide end proximate to an edge of the wound filler, the
wide end having a width greater than the narrow end; and wherein
the bands of the first pattern alternate with the bands of the
second pattern.
14. The wound filler of claim 13, wherein the bands of the first
pattern and the bands of the second pattern are curved.
15. The wound filler of either of claim 13 or 14, wherein the bands
of the first pattern and the bands of the second pattern form a
sunburst pattern.
16. The wound filler of any of claim 13, 14, or 15, wherein the
bands of the first pattern and the bands of the second pattern form
a swirl pattern.
17. The wound filler of any of claims 1-16, wherein the first
portion and the second portion are vertically arranged so that one
of the first portion and the second portion is vertically over the
other of the second portion and the first portion.
18. The wound filler of any of claims 1-16, wherein the first
portion and the second portion are horizontally arranged so that
one of the first portion and the second portion is laterally
adjacent the other of the second portion and the first portion.
19. The wound filler of any of claims 1-18, wherein the first
portion and the second portion comprise a mesh.
20. The wound filler of any of claims 1-19, wherein the first
portion comprises fibers of the first color and the second portion
comprises fibers of the second color.
21. The wound filler of any of claims 1-20, wherein the first
portion is separable from the second portion.
22. The wound filler of any of claims 1-21, wherein the first color
and the second color are configured to shift in response to
exposure to a tissue site.
23. The wound filler of claim 22, wherein the shift comprises
changing from a solid color to a pattern.
24. A method of manufacturing a tissue interface: providing a first
part having a first hue; providing a second part having a second
hue, wherein the first hue and the second hue are distinguishable
from each other and a tissue site; and joining the first part to
the second part to form a whole having visually distinguishable
sections.
25. The method of claim 24, wherein the tissue interface comprises
a foam and joining the first part to the second part comprises
bonding the first part to the second part.
26. The method of claim 24, wherein the tissue interface comprises
a foam and joining the first part to the second part comprises
fusing the first part to the second part.
27. The method of any of claims 24-26, wherein: providing the first
part comprises: feeding first ingredients to a first nozzle, mixing
the first ingredients in the first nozzle to form a first mixture,
generating a gas, infusing the first mixture with the gas to expand
the first mixture, and extruding the first mixture with the first
nozzle to form a first foam; and providing the second part
comprises: feeding second ingredients to a second nozzle, mixing
the second ingredients in the second nozzle to form a second
mixture, generating a gas, infusing the second mixture with the gas
to expand the second mixture, and extruding the second mixture with
the second nozzle to form a second foam.
28. The method of claim 27, wherein the first ingredients and the
second ingredients comprise isocyanates, polyols, and pigments.
29. The method of any of claims 24-28, wherein: providing the first
part comprises feeding first ingredients to a nozzle to form a
first mixture; providing the second part comprises feeding second
ingredients to the nozzle to form a second mixture; and the method
further comprises: co-extruding the first mixture with the nozzle
to form a first stripe, and the second mixture with the nozzle to
form a second stripe.
30. The method of either of claim 27 or 29, wherein the first
ingredients and the second ingredients comprise isocyanates,
polyols, and pigments.
31. The method of any of claims 24-30, wherein: providing the first
part comprises: filling a first container with a first liquid
polymer, and heating the first liquid polymer to form a first foam;
and providing the second part comprises: filling a second container
with a second liquid polymer, and heating the second liquid polymer
to form a second foam.
32. The method of any of claims 24-31, wherein: providing the first
part comprises: extruding a first liquid polymer into a container
to form a first stripe; providing the second part comprises:
extruding a second liquid polymer into the container to form a
second stripe; partially-mixing the first stripe and the second
stripe; and heating the first liquid polymer and the second liquid
polymer.
33. A tissue interface for use with a negative-pressure therapy
system, the tissue interface comprising: a first portion having a
first color formed in a first pattern; a second portion having a
second color formed in a second pattern; the second color having a
contrast to the first color; and the first color and the second
color having a contrast to tissue.
34. The tissue interface of claim 33, further comprising a third
portion having a third color formed in a third pattern, the third
color having a contrast to both the first color and the second
color.
35. The tissue interface of either of claim 33 or 34, wherein the
first color is white.
36. The tissue interface of any of claims 33-35, wherein the second
color is black.
37. The tissue interface of any of claims 33-35, wherein the first
color is white and the second color is black.
38. The tissue interface of any of claims 33-37, wherein the first
color does not include red.
39. The tissue interface of any of claims 33-38, wherein the first
color does not include purple.
40. The tissue interface of any of claims 33-39, wherein the second
color does not include red.
41. The tissue interface of any of claims 33-40, wherein the second
color does not include purple.
42. The tissue interface of any of claims 33-41, wherein the first
color and the second color do not include red and purple.
43. The tissue interface of any of claims 33-42, wherein the first
pattern comprises stripes, and the second pattern comprises
corresponding stripes.
44. The tissue interface of claim 43, wherein the stripes of the
first pattern and the second pattern have a width between about 2
mm and about 10 mm.
45. The tissue interface of either of claim 43 or 44, wherein: the
stripes of the first pattern have a first width; the stripes of the
second pattern have a second width; and the first width is
different from the second width.
46. The tissue interface of either of claim 43 or 44, wherein: the
stripes of the first pattern have a first width; the stripes of the
second pattern have a second width; and the first width is the same
as the second width.
47. The tissue interface of any of claims 33-46, wherein the first
pattern comprises first rings, and the second pattern comprises
second rings.
48. The tissue interface of claim 47, wherein the second rings are
concentric with the first rings.
49. The tissue interface of any of claims 33-48, wherein: the first
pattern comprises bands having a narrow end proximate to a center
of the tissue interface and a second end having a wide end
proximate to an edge of the tissue interface, the wide end having a
width greater than the narrow end; the second pattern comprises
bands having a narrow end proximate to a center of the tissue
interface and a second end having a wide end proximate to an edge
of the tissue interface, the wide end having a width greater than
the narrow end; and wherein the bands of the first pattern
alternate with the bands of the second pattern.
50. The tissue interface of claim 49, wherein the bands of the
first pattern and the bands of the second pattern are curved.
51. The tissue interface of either of claim 49 or 50, wherein the
bands of the first pattern and the bands of the second pattern form
a sunburst pattern.
52. The tissue interface of any of claims 49-51, wherein the bands
of the first pattern and the bands of the second pattern form a
swirl pattern.
53. The tissue interface of any of claims 33-52, wherein the first
portion and the second portion are vertically arranged so that one
of the first portion and the second portion is vertically over the
other of the second portion and the first portion.
54. The tissue interface of any of claims 33-52, wherein the first
portion and the second portion are horizontally arranged so that
one of the first portion and the second portion is laterally
adjacent the other of the second portion and the first portion.
55. A system for treating a tissue site with negative pressure, the
system comprising: a manifold configured to be positioned adjacent
to the tissue site, the manifold comprising: a first portion having
a first color; a second portion having a second color, the second
color having a contrast to the first color; and the first color and
the second color having a contrast to red and purple; a cover
configured to be positioned over the manifold to form a sealed
space containing the manifold; and a negative-pressure source
fluidly coupled to the sealed space to draw fluid across the
manifold, thereby generating a negative pressure.
56. The system of claim 55, further comprising the manifold having
a third portion having a third color, the third color having a
contrast to both the first color and the second color.
57. The system of either of claim 55 or 56, wherein the first color
is white.
58. The system of any of claims 55-57, wherein the second color is
black.
59. The system of any of claims 55-57, wherein the first color is
white and the second color is black.
60. The system of any of claims 55-59, wherein: the first portion
has a first pattern; and the second portion has a second
pattern.
61. The system of claim 60, wherein the first pattern comprises
stripes, and the second pattern comprises corresponding
stripes.
62. The system of claim 61, wherein the stripes of the first
pattern and the second pattern have a width between about 2 mm and
about 10 mm.
63. The system of claim 61 or 62, wherein: the stripes of the first
pattern have a first width; the stripes of the second pattern have
a second width; and the first width is different from the second
width.
64. The system of either of claim 61 or 62, wherein: the stripes of
the first pattern have a first width; the stripes of the second
pattern have a second width; and the first width is the same as the
second width.
65. The system of any of claims 60-64, wherein the first pattern
comprises first rings, and the second pattern comprises second
rings.
66. The system of claim 65, wherein the second rings are concentric
with the first rings.
67. The system of any of claims 60-66, wherein: the first pattern
comprises bands having a narrow end proximate to a center of the
system and a second end having a wide end proximate to an edge of
the system, the wide end having a width greater than the narrow
end; the second pattern comprises bands having a narrow end
proximate to a center of the system and a second end having a wide
end proximate to an edge of the system, the wide end having a width
greater than the narrow end; and wherein the bands of the first
pattern alternate with the bands of the second pattern.
68. The system of claim 67, wherein the bands of the first pattern
and the bands of the second pattern are curved.
69. The system of either of claim 67 or 68, wherein the bands of
the first pattern and the bands of the second pattern form a
sunburst pattern.
70. The system of any of claims 67-69, wherein the bands of the
first pattern and the bands of the second pattern form a swirl
pattern.
71. The system of any of claims 55-70, wherein the first portion
and the second portion are vertically arranged so that one of the
first portion and the second portion is vertically over the other
of the second portion and the first portion.
72. The system of any of claims 55-70, wherein the first portion
and the second portion are horizontally arranged so that one of the
first portion and the second portion is laterally adjacent the
other of the second portion and the first portion.
73. The system of any of claims 55-72, wherein the first portion
comprises fibers of the first color and the second portion
comprises fibers of the second color.
74. The system of any of claims 55-73, wherein the first portion is
separable from the second portion.
75. The system of any of claims 55-74, wherein the first color and
the second color are configured to shift in response to exposure to
a tissue site.
76. The system of claim 75, wherein the shift comprises changing
from a solid color to a pattern.
77. A tissue interface having a first portion having a first color,
a second portion having a second color, the first color
distinguishable from the second color, and the first color and the
second color distinguishable from tissue, the tissue interfaced
produced by a process comprising: providing a first part having a
first hue; providing a second part having a second hue, wherein the
first hue and the second hue are distinguishable from each other
and a tissue site; and joining the first part to the second part to
form a whole having visually distinguishable sections.
78. The tissue interface of claim 77, wherein the tissue interface
comprises a foam and joining the first part to the second part
comprises bonding the first part to the second part.
79. The tissue interface of claim 77, wherein the tissue interface
comprises a foam and joining the first part to the second part
comprises fusing the first part to the second part.
80. The tissue interface of any of claims 77-79, wherein: providing
the first part comprises: feeding first ingredients to a first
nozzle, mixing the first ingredients in the first nozzle to form a
first mixture, generating a gas, infusing the first mixture with
the gas to expand the first mixture, and extruding the first
mixture with the first nozzle to form a first foam; and providing
the second part comprises: feeding second ingredients to a second
nozzle, mixing the second ingredients in the second nozzle to form
a second mixture, generating a gas, infusing the second mixture
with the gas to expand the second mixture, and extruding the second
mixture with the second nozzle to form a second foam.
81. The tissue interface of claim 80, wherein the first ingredients
and the second ingredients comprise isocyanates, polyols, and
pigments.
82. The tissue interface of any of claims 77-81, wherein: providing
the first part comprises feeding first ingredients to a nozzle to
form a first mixture; providing the second part comprises feeding
second ingredients to the nozzle to form a second mixture; and the
method further comprises: co-extruding the first mixture with the
nozzle to form a first stripe, and the second mixture with the
nozzle to form a second stripe.
83. The tissue interface of claim 82, wherein the first ingredients
and the second ingredients comprise isocyanates, polyols, and
pigments.
84. The tissue interface of any of claims 77-83, wherein: providing
the first part comprises: filling a first container with a first
liquid polymer, and heating the first liquid polymer to form a
first foam; and providing the second part comprises: filling a
second container with a second liquid polymer, and heating the
second liquid polymer to form a second foam.
85. The tissue interface of any of claims 77-84, wherein: providing
the first part comprises: extruding a first liquid polymer into a
container to form a first stripe; providing the second part
comprises: extruding a second liquid polymer into the container to
form a second stripe; partially-mixing the first stripe and the
second stripe; and heating the first liquid polymer and the second
liquid polymer.
86. The systems, methods, and apparatuses as described herein.
Description
RELATED APPLICATIONS
[0001] The present invention claims the benefit, under 35 USC
.sctn. 119(e), of the filing of U.S. Provisional Patent Application
Ser. No. 62/461,603, entitled "DIFFERENTIAL CONTRAST WOUND FILLER,"
filed Feb. 21, 2017. This provisional application is incorporated
herein by reference by all purposes.
TECHNICAL FIELD
[0002] The invention set forth in the appended claims relates
generally to tissue treatment systems and more particularly, but
without limitation, to a tissue interface having visually
contrasting portions for identification of the tissue interface
during removal from a tissue site.
BACKGROUND
[0003] Clinical studies and practice have shown that reducing
pressure in proximity to a tissue site can augment and accelerate
growth of new tissue at the tissue site. The applications of this
phenomenon are numerous, but it has proven particularly
advantageous for treating wounds. Regardless of the etiology of a
wound, whether trauma, surgery, or another cause, proper care of
the wound is important to the outcome. Treatment of wounds or other
tissue with reduced pressure may be commonly referred to as
"negative-pressure therapy," but is also known by other names,
including "negative-pressure wound therapy," "reduced-pressure
therapy," "vacuum therapy," "vacuum-assisted closure," and "topical
negative-pressure," for example. Negative-pressure therapy may
provide a number of benefits, including migration of epithelial and
subcutaneous tissues, improved blood flow, and micro-deformation of
tissue at a wound site. Together, these benefits can increase
development of granulation tissue and reduce healing times.
[0004] There is also widespread acceptance that cleansing a tissue
site can be highly beneficial for new tissue growth. For example, a
wound can be washed out with a stream of liquid solution, or a
cavity can be washed out using a liquid solution for therapeutic
purposes. These practices are commonly referred to as "irrigation"
and "lavage" respectively. "Instillation" is another practice that
generally refers to a process of slowly introducing fluid to a
tissue site and leaving the fluid for a prescribed period of time
before removing the fluid. For example, instillation of topical
treatment solutions over a wound bed can be combined with
negative-pressure therapy to further promote wound healing by
loosening soluble contaminants in a wound bed and removing
infectious material. As a result, soluble bacterial burden can be
decreased, contaminants removed, and the wound cleansed.
[0005] While the clinical benefits of negative-pressure therapy
and/or instillation therapy are widely known, improvements to
therapy systems, components, and processes may benefit healthcare
providers and patients.
BRIEF SUMMARY
[0006] New and useful systems, apparatuses, and methods for
identifying a tissue interface in a tissue site during dressing
changes and at the conclusion of therapy are set forth in the
appended claims. Illustrative embodiments are also provided to
enable a person skilled in the art to make and use the claimed
subject matter.
[0007] For example, in some embodiments, a wound filler is
described. The wound filler can include a first portion having a
first color and a second portion having a second color. The second
color can contrast to the first color. The first color and the
second color can contrast to red and purple.
[0008] More generally, a method of manufacturing a tissue interface
is provided. A first part having a first hue can be provided. A
second part having a second hue can also be provided. The first hue
and the second hue are distinguishable from each other and a tissue
site. The first part can be joined to the second part to form a
whole having visually distinguishable sections.
[0009] Alternatively, other example embodiments may describe a
tissue interface for use with a negative-pressure therapy system.
The tissue interface can include a first portion having a first
color formed in a first pattern and a second portion having a
second color formed in a second pattern. The second color can have
a contrast to the first color, and the first color and the second
color can have a contrast to tissue.
[0010] A system for treating a tissue site with negative pressure
is also described herein. The system can include a manifold
configured to be positioned adjacent to the tissue site. The
manifold can have a first portion having a first color and a second
portion having a second color. The second color can contrast to the
first color. The first color and the second color can contrast to
red and purple. The system can further include a cover configured
to be positioned over the manifold to form a sealed space
containing the manifold. A negative-pressure source can be fluidly
coupled to the sealed space to draw fluid across the manifold,
thereby generating a negative pressure.
[0011] Another tissue interface is also described herein. The
tissue interface can have a first portion having a first color, a
second portion having a second color, the first color being
distinguishable from the second color, and the first color and the
second color being distinguishable from tissue. The tissue
interface can be produced by providing a first part having a first
hue; and providing a second part having a second hue. The first hue
and the second hue can be distinguishable from each other and a
tissue site. The first part can be joined to the second part to
form a whole having visually distinguishable sections.
[0012] Objectives, advantages, and a preferred mode of making and
using the claimed subject matter may be understood best by
reference to the accompanying drawings in conjunction with the
following detailed description of illustrative embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a sectional schematic view of an example
embodiment of a therapy system that can provide a sealed
therapeutic environment in accordance with this specification;
[0014] FIG. 2 is a perspective view of a tissue interface,
illustrating additional details that may be associated with an
example embodiment of the therapy system of FIG. 1;
[0015] FIG. 3A is perspective view of a first tissue interface
having a first contrasting marker, illustrating additional details
that may be associated with a manufacturing process of the tissue
interface of FIG. 2;
[0016] FIG. 3B is perspective view of a second tissue interface
having a second contrasting marker, illustrating additional details
that may be associated with the manufacturing process of the tissue
interface of FIG. 2;
[0017] FIG. 4A is perspective view of the first tissue interface
having the first contrasting marker, illustrating additional
details that may be associated with the manufacturing process of
the tissue interface of FIG. 2;
[0018] FIG. 4B is perspective view of the second tissue interface
having the second contrasting marker, illustrating additional
details that may be associated with the manufacturing process of
the tissue interface of FIG. 2;
[0019] FIG. 5A is perspective view of the first tissue interface
having the first contrasting marker, illustrating additional
details that may be associated with the manufacturing process of
the tissue interface of FIG. 2;
[0020] FIG. 5B is perspective view of the second tissue interface
having the second contrasting marker, illustrating additional
details that may be associated with the manufacturing process of
the tissue interface of FIG. 2;
[0021] FIG. 6 is a perspective exploded view of the tissue
interface of FIG. 2, illustrating additional details that may be
associated the manufacturing process of the tissue interface of
FIG. 2;
[0022] FIG. 7 is a perspective view of another tissue interface
illustrating additional details that may be associated with an
example embodiment of the therapy system of FIG. 1;
[0023] FIG. 8 is a perspective color view of the tissue interface
of FIG. 7; and
[0024] FIG. 9 is a schematic view of a manufacturing system for
example embodiments of the tissue interfaces of FIGS. 2-8.
DESCRIPTION OF EXAMPLE EMBODIMENTS
[0025] The following description of example embodiments provides
information that enables a person skilled in the art to make and
use the subject matter set forth in the appended claims, but may
omit certain details already well-known in the art. The following
detailed description is, therefore, to be taken as illustrative and
not limiting.
[0026] The example embodiments may also be described herein with
reference to spatial relationships between various elements or to
the spatial orientation of various elements depicted in the
attached drawings. In general, such relationships or orientation
assume a frame of reference consistent with or relative to a
patient in a position to receive treatment. However, as should be
recognized by those skilled in the art, this frame of reference is
merely a descriptive expedient rather than a strict
prescription.
[0027] FIG. 1 is a sectional schematic view of an example
embodiment of a therapy system 100 that can provide a sealed
therapeutic environment, negative-pressure therapy, and/or
instillation of topical treatment solutions in accordance with this
specification. The term "tissue site" in this context broadly
refers to a wound, defect, or other treatment target located on or
within tissue, including but not limited to, bone tissue, adipose
tissue, muscle tissue, neural tissue, dermal tissue, vascular
tissue, connective tissue, cartilage, tendons, or ligaments. A
wound may include chronic, acute, traumatic, subacute, and dehisced
wounds, partial-thickness burns, ulcers (such as diabetic,
pressure, or venous insufficiency ulcers), flaps, and grafts, for
example. The term "tissue site" may also refer to areas of any
tissue that are not necessarily wounded or defective, but are
instead areas in which it may be desirable to add or promote the
growth of additional tissue. For example, negative pressure may be
applied to a tissue site to grow additional tissue that may be
harvested and transplanted.
[0028] The therapy system 100 may include a negative-pressure
supply, and may include or be configured to be coupled to a
distribution component, such as a dressing. In general, a
distribution component may refer to any complementary or ancillary
component configured to be fluidly coupled to a negative-pressure
supply in a fluid path between a negative-pressure supply and a
tissue site. A distribution component is preferably detachable, and
may be disposable, reusable, or recyclable. For example, a dressing
102 may be fluidly coupled to a negative-pressure source 104, as
illustrated in FIG. 1. A dressing may include a cover, a tissue
interface, or both in some embodiments. The dressing 102, for
example, may include a cover 106 and a tissue interface 108. A
regulator or a controller may also be coupled to the
negative-pressure source 104 or a component of the
negative-pressure source 104.
[0029] In some embodiments, a dressing interface 110 may facilitate
coupling the negative-pressure source 104 to the dressing 102. For
example, such a dressing interface may be a T.R.A.C..RTM. Pad or
Sensa T.R.A.C..RTM. Pad available from KCI of San Antonio, Tex..
The therapy system 100 may optionally include a fluid container
coupled to the dressing 102 and to the negative-pressure source
104.
[0030] The therapy system 100 may also include a source of
instillation solution. For example, a solution source may be
fluidly coupled to the dressing. The solution source may be fluidly
coupled to a positive-pressure source in some embodiments, or may
be fluidly coupled to the negative-pressure source 104. A regulator
may also be fluidly coupled to the solution source and the dressing
102. In some embodiments, a regulator may also be fluidly coupled
to the negative-pressure source 104 through the dressing 102.
[0031] Additionally, the therapy system 100 may include sensors to
measure operating parameters and provide feedback signals to the
controller indicative of the operating parameters. For example, the
therapy system 100 may include a pressure sensor, an electric
sensor, or both, coupled to the controller. The pressure sensor may
also be coupled or configured to be coupled to a distribution
component and to the negative-pressure source 104.
[0032] Components may be fluidly coupled to each other to provide a
path for transferring fluids (i.e., liquid and/or gas) between the
components. For example, components may be fluidly coupled through
a fluid conductor, such as a tube. A "tube," as used herein,
broadly includes a tube, pipe, hose, conduit, or other structure
with one or more lumina adapted to convey a fluid between two ends.
Typically, a tube is an elongated, cylindrical structure with some
flexibility, but the geometry and rigidity may vary. In some
embodiments, components may also be coupled by virtue of physical
proximity, being integral to a single structure, or being formed
from the same piece of material. Moreover, some fluid conductors
may be molded into or otherwise integrally combined with other
components. Coupling may also include mechanical, thermal,
electrical, or chemical coupling (such as a chemical bond) in some
contexts. For example, a tube may mechanically and fluidly couple
the dressing 102 to a container in some embodiments.
[0033] In general, components of the therapy system 100 may be
coupled directly or indirectly. For example, the negative-pressure
source 104 may be directly coupled to a controller, and may be
indirectly coupled to the dressing 102 through a tube 112.
[0034] The fluid mechanics of using a negative-pressure source to
reduce pressure in another component or location, such as within a
sealed therapeutic environment, can be mathematically complex.
However, the basic principles of fluid mechanics applicable to
negative-pressure therapy and instillation are generally well-known
to those skilled in the art, and the process of reducing pressure
may be described illustratively herein as "delivering,"
"distributing," or "generating" negative pressure, for example.
[0035] In general, exudates and other fluids flow toward lower
pressure along a fluid path. Thus, the term "downstream" typically
implies a position in a fluid path relatively closer to a source of
negative pressure or further away from a source of positive
pressure. Conversely, the term "upstream" implies a position
relatively further away from a source of negative pressure or
closer to a source of positive pressure. Similarly, it may be
convenient to describe certain features in terms of fluid "inlet"
or "outlet" in such a frame of reference. This orientation is
generally presumed for purposes of describing various features and
components herein. However, the fluid path may also be reversed in
some applications (such as by substituting a positive-pressure
source for a negative-pressure source) and this descriptive
convention should not be construed as a limiting convention.
[0036] "Negative pressure" generally refers to a pressure less than
a local ambient pressure, such as the ambient pressure in a local
environment external to a sealed therapeutic environment provided
by the dressing 102. In many cases, the local ambient pressure may
also be the atmospheric pressure at which a tissue site is located.
Alternatively, the pressure may be less than a hydrostatic pressure
associated with tissue at the tissue site. Unless otherwise
indicated, values of pressure stated herein are gauge pressures.
Similarly, references to increases in negative pressure typically
refer to a decrease in absolute pressure, while decreases in
negative pressure typically refer to an increase in absolute
pressure. While the amount and nature of negative pressure applied
to a tissue site may vary according to therapeutic requirements,
the pressure is generally a low vacuum, also commonly referred to
as a rough vacuum, between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7
kPa). Common therapeutic ranges are between -75 mm Hg (-9.9 kPa)
and -300 mm Hg (-39.9 kPa).
[0037] A negative-pressure supply, such as the negative-pressure
source 104, may be a reservoir of air at a negative pressure, or
may be a manual or electrically-powered device that can reduce the
pressure in a sealed volume, such as a vacuum pump, a suction pump,
a wall suction port available at many healthcare facilities, or a
micro-pump, for example. A negative-pressure supply may be housed
within or used in conjunction with other components, such as
sensors, processing units, alarm indicators, memory, databases,
software, display devices, or user interfaces that further
facilitate therapy. For example, in some embodiments, the
negative-pressure source 104 may be combined with the controller
and other components into a therapy unit. A negative-pressure
supply may also have one or more supply ports configured to
facilitate coupling and de-coupling the negative-pressure supply to
one or more distribution components.
[0038] The tissue interface 108 can be generally adapted to contact
a tissue site to act as a wound filler, a device used to fill the
negative space of a tissue site. The tissue interface 108 may be
partially or fully in contact with the tissue site. If the tissue
site is a wound, for example, the tissue interface 108 may
partially or completely fill the wound, or may be placed over the
wound. The tissue interface 108 may take many forms, and may have
many sizes, shapes, or thicknesses depending on a variety of
factors, such as the type of treatment being implemented or the
nature and size of a tissue site. For example, the size and shape
of the tissue interface 108 may be adapted to the contours of deep
and irregular shaped tissue sites. Moreover, any or all of the
surfaces of the tissue interface 108 may have projections or an
uneven, course, or jagged profile that can induce strains and
stresses on a tissue site, which can promote granulation at the
tissue site.
[0039] In some embodiments, the tissue interface 108 may be a
manifold. A "manifold" in this context generally includes any
substance or structure providing a plurality of pathways adapted to
collect or distribute fluid across a tissue site under pressure.
For example, a manifold may be adapted to receive negative pressure
from a source and distribute negative pressure through multiple
apertures across a tissue site, which may have the effect of
collecting fluid from across a tissue site and drawing the fluid
toward the source. In some embodiments, the fluid path may be
reversed or a secondary fluid path may be provided to facilitate
delivering fluid across a tissue site.
[0040] In some illustrative embodiments, the pathways of a manifold
may be interconnected to improve distribution or collection of
fluids across a tissue site. In some illustrative embodiments, a
manifold may be a porous foam material having interconnected cells
or pores. For example, cellular foam, open-cell foam, reticulated
foam, porous tissue collections, and other porous material such as
gauze or felted mat generally include pores, edges, and/or walls
adapted to form interconnected fluid channels. Liquids, gels, and
other foams may also include or be cured to include apertures and
fluid pathways. In some embodiments, a manifold may additionally or
alternatively comprise projections that form interconnected fluid
pathways. For example, a manifold may be molded to provide surface
projections that define interconnected fluid pathways.
[0041] The average pore size of a foam may vary according to needs
of a prescribed therapy. For example, the tissue interface 108 may
be a foam having pore sizes in a range of about 400 to about 600
microns. The tensile strength of the tissue interface 108 may also
vary according to needs of a prescribed therapy. For example, the
tensile strength of a foam may be increased for instillation of
topical treatment solutions. In one non-limiting example, the
tissue interface 108 may be an open-cell, reticulated polyurethane
foam such as GranuFoam.RTM. dressing or VeraFlo.RTM. foam, both
available from Kinetic Concepts, Inc. of San Antonio, Tex.
[0042] The tissue interface 108 may be either hydrophobic or
hydrophilic. In an example in which the tissue interface 108 may be
hydrophilic, the tissue interface 108 may also wick fluid away from
a tissue site, while continuing to distribute negative pressure to
the tissue site. The wicking properties of the tissue interface 108
may draw fluid away from a tissue site by capillary flow or other
wicking mechanisms. An example of a hydrophilic foam is a polyvinyl
alcohol, open-cell foam such as V.A.C. WhiteFoam.RTM. dressing
available from Kinetic Concepts, Inc. of San Antonio, Tex. Other
hydrophilic foams may include those made from polyether. Other
foams that may exhibit hydrophilic characteristics include
hydrophobic foams that have been treated or coated to provide
hydrophilicity.
[0043] The tissue interface 108 may further promote granulation at
a tissue site when pressure within the sealed therapeutic
environment is reduced. For example, any or all of the surfaces of
the tissue interface 108 may have an uneven, coarse, or jagged
profile that can induce microstrains and stresses at a tissue site
if negative pressure is applied through the tissue interface
108.
[0044] In some embodiments, the tissue interface 108 may be
constructed from bioresorbable materials. Suitable bioresorbable
materials may include, without limitation, a polymeric blend of
polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric
blend may also include without limitation polycarbonates,
polyfumarates, and capralactones. The tissue interface 108 may
further serve as a scaffold for new cell-growth, or a scaffold
material may be used in conjunction with the tissue interface 108
to promote cell-growth. A scaffold is generally a substance or
structure used to enhance or promote the growth of cells or
formation of tissue, such as a three-dimensional porous structure
that provides a template for cell growth. Illustrative examples of
scaffold materials include calcium phosphate, collagen, PLA/PGA,
coral hydroxy apatites, carbonates, or processed allograft
materials.
[0045] In some embodiments, the cover 106 may provide a bacterial
barrier and protection from physical trauma. The cover 106 may also
be constructed from a material that can reduce evaporative losses
and provide a fluid seal between two components or two
environments, such as between a therapeutic environment and a local
external environment. The cover 106 may be, for example, an
elastomeric film or membrane that can provide a seal adequate to
maintain a negative pressure at a tissue site for a given
negative-pressure source. The cover 106 may have a high
moisture-vapor transmission rate (MVTR) in some applications. For
example, the MVTR may be at least 300 g/m{circumflex over ( )}2 per
twenty-four hours in some embodiments. In some example embodiments,
the cover 106 may be a polymer drape, such as a polyurethane film,
that is permeable to water vapor but impermeable to liquid. Such
drapes typically have a thickness in the range of about 25 microns
to about 50 microns. For permeable materials, the permeability
generally should be low enough that a desired negative pressure may
be maintained.
[0046] An attachment device 114 may be used to attach the cover 106
to an attachment surface, such as undamaged epidermis, a gasket, or
another cover. The attachment device 114 may take many forms. For
example, an attachment device may be a medically-acceptable,
pressure-sensitive adhesive that extends about a periphery, a
portion, or an entire sealing member. In some embodiments, for
example, some or all of the cover 106 may be coated with an acrylic
adhesive having a coating weight between about 25 to about 65 grams
per square meter (g.s.m.). Thicker adhesives, or combinations of
adhesives, may be applied in some embodiments to improve the seal
and reduce leaks. Other example embodiments of an attachment device
may include a double-sided tape, paste, hydrocolloid, hydrogel,
silicone gel, or organogel.
[0047] A controller may be a microprocessor or computer programmed
to operate one or more components of the therapy system 100, such
as the negative-pressure source 104. In some embodiments, for
example, the controller may be a microcontroller, which generally
comprises an integrated circuit containing a processor core and a
memory programmed to directly or indirectly control one or more
operating parameters of the therapy system 100. Operating
parameters may include the power applied to the negative-pressure
source 104, the pressure generated by the negative-pressure source
104, or the pressure distributed to the tissue interface 108, for
example. The controller is also preferably configured to receive
one or more input signals, such as a feedback signal, and
programmed to modify one or more operating parameters based on the
input signals.
[0048] Sensors, such as the pressure sensor or the electric sensor,
are generally known in the art as any apparatus operable to detect
or measure a physical phenomenon or property, and generally provide
a signal indicative of the phenomenon or property that is detected
or measured. For example, the pressure sensor and the electric
sensor may be configured to measure one or more operating
parameters of the therapy system 100. In some embodiments, a
pressure sensor may be a transducer configured to measure pressure
in a pneumatic pathway and convert the measurement to a signal
indicative of the pressure measured. For example, a pressure sensor
may be a piezoresistive strain gauge. An electric sensor may
optionally measure operating parameters of the negative-pressure
source, such as the voltage or current, in some embodiments.
Preferably, the signals from a pressure sensor and an electric
sensor are suitable as an input signal to the controller, but some
signal conditioning may be appropriate in some embodiments. For
example, the signal may need to be filtered or amplified before it
can be processed by the controller. Typically, the signal is an
electrical signal, but may be represented in other forms, such as
an optical signal.
[0049] A container is representative of a container, canister,
pouch, or other storage component, which can be used to manage
exudates and other fluids withdrawn from a tissue site. In many
environments, a rigid container may be preferred or required for
collecting, storing, and disposing of fluids. In other
environments, fluids may be properly disposed of without rigid
container storage, and a re-usable container could reduce waste and
costs associated with negative-pressure therapy.
[0050] A solution source may also be representative of a container,
canister, pouch, bag, or other storage component, which can provide
a solution for instillation therapy. Compositions of solutions may
vary according to a prescribed therapy, but examples of solutions
that may be suitable for some prescriptions include
hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based
solutions, biguanides, cationic solutions, and isotonic
solutions.
[0051] In operation, the tissue interface 108 may be placed within,
over, on, or otherwise proximate to a tissue site. The cover 106
may be placed over the tissue interface 108 and sealed to an
attachment surface near the tissue site. For example, the cover 106
may be sealed to undamaged epidermis peripheral to a tissue site
with the attachment device 114. Thus, the dressing 102 can provide
a sealed therapeutic environment proximate to a tissue site,
substantially isolated from the external environment, and the
negative-pressure source 104 can reduce the pressure in the sealed
therapeutic environment through the dressing interface 110.
Negative pressure applied across the tissue site through the tissue
interface 108 in the sealed therapeutic environment can induce
macrostrain and microstrain in the tissue site, as well as remove
exudates and other fluids from the tissue site, which can be
collected in the container.
[0052] Depending on the type of therapy provided and the duration
of therapy, a dressing providing a sealed therapeutic environment
over a tissue site can be changed or removed. For example, if
negative-pressure therapy has concluded, the dressing can be
removed. In another example, negative-pressure therapy encourages a
tissue site to heal and close. As the tissue site heals, the tissue
site may decrease in size. Consequently, a tissue interface that
was selected for the original size of the tissue site, may become
too large for the tissue site as the tissue site heals. If
negative-pressure therapy has not concluded, the tissue interface
may be removed and replaced with a smaller tissue interface.
[0053] The tissue interface 108 of the therapy system 100 can
assist a user to remove a tissue interface or remove and replace a
tissue interface by providing the tissue interface 108 with
visually contrasting portions. A tissue interface 108 having
visually contrasting portions increases the visibility of the
tissue interface 108 in the tissue site. For example, the tissue
interface 108 may include contrasting colors, contrasting shapes,
or both, causing the tissue interface 108 to appear to be a foreign
body. The tissue interface 108 can appear to be a foreign body even
if the tissue interface is exposed to copious amounts of exudates
or other fluids from the tissue site. In some embodiments, the
tissue interface 108 may include portions having a first
contrasting marker 116 and different portions having a second
contrasting marker 118.
[0054] In some embodiments, the first contrasting marker 116
comprises a first color and the second contrasting marker 118
comprises a second color. The first color of the first contrasting
marker 116 and the second color of the second contrasting marker
118 are complementary colors. Complementary colors are color pairs
that, if mixed, form white or black. If objects formed from two
different colors are placed adjacent each other, two colors that
are complementary may have a higher visual contrast than colors
that are not complementary. Generally, visual contrast increases
the visibility of a body. Complementary colors can be determined in
a variety of methods in view of a variety of color theories. In
different color theories, different colors are complementary pairs.
Color theory generally refers to a body of practical guidance for
the mixing of colors and the effects of a specific combination of
colors. Two example color theories will be explained herein. While
other color theories may be used, the two described provide the
basic principles by which to understand complementary color pairs.
The first color theory is a subtractive color model. The second
color theory is an additive color model.
[0055] The subtractive color model begins with the concept of white
light. Ink, paint, or filters that are applied to a subject absorb
wavelengths of the white light, subtracting the hues associated
with the absorbed wavelengths. The end result is that the
unabsorbed light is reflected back to an observer, providing the
color of the object. In the subtractive color model, red, yellow,
and blue originally formed the primary colors for the mixing of
pigments. A color wheel can be constructed based on the red,
yellow, and blue primary colors. A color wheel is an organization
of color hues around a circle. The organization illustrates the
relationship between the different colors. On the color wheel, red,
yellow, and blue occupy positions approximately 120 degrees from
each other. Secondary colors, colors formed by mixing of two of the
primary colors, are located on the circle between the primary
colors from which the secondary color was formed. Where red,
yellow, and blue are the primary colors, the secondary colors are
orange, green, and purple. Orange is formed by mixing equal parts
red and yellow and is located equidistant between red and yellow on
the color wheel. Green is formed by mixing equal parts blue and
yellow and is located equidistant between blue and yellow on the
color wheel. Purple is formed by mixing equal parts blue and red
and is located equidistant between blue and red on the color wheel.
The secondary colors of green, orange, and purple are also spaced
approximately 120 degrees from each other on the color wheel.
Colors formed by unequal mixtures of the primary colors of red,
yellow, and blue are positioned relative to the primary and
secondary colors based on the relative percentages of the primary
colors that form the color. For example, color hues having more
blue than red are disposed on the color wheel between purple and
blue, with the percentage of blue forming the color increasing the
closer the color is positioned to blue. Generally, colors which are
opposite each other on the color wheel are considered
complementary. In the subtractive color model, the complementary
pair to red is green, to yellow is purple, and to blue is
orange.
[0056] The additive color model mixes colors to arrive at an end
result. Additive color models add colors of light associated with
particular hues, and the resulting combination of colored light
produces a resulting color. In the additive color model, the three
primary colors are red, green, and blue. As the three primary
colors, red, green, and blue will be positioned equidistantly from
each other on a color wheel. The secondary colors in the additive
color model are yellow, cyan, and magenta. Yellow is formed by
mixing equal parts red and green and is located equidistant between
red and green on the color wheel. Cyan is formed by mixing equal
parts green and blue and is located equidistant between green and
blue on the color wheel. Magenta is formed by mixing equal parts
blue and red and is located equidistant between blue and red on the
color wheel. The secondary colors of yellow, cyan, and magenta are
also spaced approximately 120 degrees from each other on the color
wheel. Colors formed by unequal mixtures of the primary colors of
green, red, and blue are positioned relative to the primary and
secondary colors based on the relative percentages of the primary
colors that form the color. For example, color hues having more red
than blue are disposed on the color wheel between magenta and red,
with the percentage of red forming the color increasing the closer
the color is positioned to red. The complementary color to red is
cyan; the complementary color to green is magenta; and the
complementary color to blue is yellow.
[0057] Printing and digital representation of color, such as on a
computer monitor, generally rely on the additive color model. For
many modern printing and digital color representations, the primary
colors are cyan, magenta, and yellow, and the complementary pairs
are magenta and green, yellow and blue, and cyan and red. In
digital reproduction, for example on a computer screen, colors can
be defined by a code number identified as an sRGB number, which
processors and computer programs use to define the intensity of the
color Red, the color Green, and the color Blue for a particular
shade. Color can also be represented in a hex triplet, a six-digit,
three-byte hexadecimal number used in hypertext markup language
("HTML"), cascading style sheets ("CSS"), scalable vector graphics
("SVG"), and other computer applications to represent colors.
[0058] The color red can have a light wavelength between about 620
nanometers (nm) and about 740 nm and has a frequency between about
400 terehertz (THz) and about 480 THz. For red, the sRGB number is
255, 00, 00. In hex triplet, red is represented by the code #
FF0000. Traditionally, in the subtractive color model, the
complementary color of red is green. In the additive color model,
the complementary color of red is cyan. The color cyan has a light
wavelength between about 490 nm and about 520 nm and has a
frequency between about 575 THz and about 610 THz. In digital
representation, the sRGB number is 00, 255, 255, and the hex
triplet number is #00FFFF.
[0059] The color green can have a light wavelength between about
500 nm and about 575 nm and has a frequency between about 525 THz
and about 575 THz. The sRGB number for green is 00, 255, 00, and
the hex triplet number is #00FF00. In the additive color model, the
complimentary color of green is magenta. The color magenta is a
composite color or an extra-spectral color of red and blue and, as
a result, is not represented in the visible light spectrum. The
sRGB number is 255, 00, 255, and the hex triplet number is #
FF00FF.
[0060] The color blue can have a light wavelength between about 445
nm and about 500 nm and has a frequency between about 610 THz and
about 670 THz. The sRGB number is 00, 00, 255, and the hex triplet
representation is #0000FF. Traditionally, in the subtractive color
model, the complementary color of blue is orange. The color orange
has a light wavelength between about 585 nm and about 620 nm and
has a frequency between about 480 THz and about 505 THz. The sRGB
number is 255, 128, 00, and the hex triplet number is # FF8000. In
the additive color model, the complementary color of blue is
yellow. The color yellow has a light wavelength between about 575
nm and about 585 nm and has a frequency between about 512 THz and
about 521 THz. The sRGB number is 255, 255, 00, and the hex triplet
number is # FFFF00. Traditionally, in the subtractive color model,
the complementary color of yellow is purple. The color purple can
be considered a composite color or extra-spectral color of red and
blue and, as a result, is not represented in the visible light
spectrum. In digital representation, the sRGB number is 128, 00,
128, and the hex triplet number is
[0061] The first contrasting markers 116 and the second contrasting
markers 118 may typically be primary/complementary color pairs. For
example, the first contrasting marker 116 can be red, and the
second contrasting marker 118 can be green or cyan. Similarly, if
the first contrasting marker 116 is blue, the second contrasting
marker 118 can be orange or yellow, and if the first contrasting
marker 116 is yellow, the second contrasting marker 118 can be
purple or blue. If the first contrasting marker 116 is green, the
second contrasting marker 118 can be magenta or red. In some
embodiments, the first contrasting marker 116 may be white and the
second contrasting marker 118 may be black. In other embodiments,
the first contrasting marker 116 may be black and the second
contrasting marker 118 may be white. Colors having a hue similar to
that of tissue, such as purples or reds, may blend with the tissue
of the tissue site and may not be preferred.
[0062] The tissue interface 108 includes a first portion having the
first contrasting marker 116 and a second portion having the second
contrasting marker 118. The first portion having the first
contrasting marker 116 and the second portion having the second
contrasting marker 118 can form the entirety of the tissue
interface 108. In some embodiments, the first portion having the
first contrasting marker 116 and the second portion having the
second contrasting marker 118 each form approximately half of the
tissue interface 108. In other embodiments, the first portion
having the first contrasting marker 116 and the second portion
having the second contrasting marker 118 may form unequal portions
of the tissue interface 108. The first contrasting marker 116 and
the second contrasting marker 118 create a visual contrast in the
tissue site. The tissue interface 108 being non-monochromatic,
creates a visual change as the tissue site is visually scanned from
one side to the other, allowing a user to readily identify the
tissue interface 108 in the tissue site. If the tissue interface
108 is saturated with fluids from the tissue site, the tissue
interface 108 does not appear visually the same as the tissue site
is scanned. The complementary colors of the first contrasting
marker 116 and the second contrasting marker 118 can cause the
portion of the tissue interface 108 having the first contrasting
marker 116 to appear visually different from the portion of the
tissue interface 108 having the second contrasting marker 118. The
juxtaposition of the first contrasting marker 116 and the second
contrasting marker 118 can draw the eye of the use, allowing the
user to identify the tissue interface 108, even if saturated with
fluids from the tissue site.
[0063] In some embodiments, fluorescent hues of the complementary
color pairs may be used for the first contrasting marker 116 and
the second contrasting marker 118. In some embodiments, ornamental
patterns may be added to the first contrasting marker 116 and the
second contrasting marker 118 to assist in identification of the
tissue interface 108. For example, the first contrasting maker 116
and the second and the second contrasting marker 118 can be
disposed in portions of the tissue interface 108 so that the
portions having the first contrasting marker 116 may form polygonal
shapes, including letters, numbers, or other similar features.
Similarly, the portions having the second contrasting marker 118
may form polygonal shapes, including letters, numbers, or other
similar features.
[0064] FIG. 2 is a perspective view illustrating additional details
that may be associated with some example embodiments of another
tissue interface 208. The tissue interface 208 may be similar to
and operate as described above with respect to the tissue interface
108. The tissue interface 208 can include the first contrasting
marker 116 and the second contrasting marker 118 formed into a
pattern. For example, the tissue interface 208 can comprise bands
or a plurality of strips of the first contrasting markers 116 and a
plurality of strips of the second contrasting markers 118. The
strips of the first contrasting marker 116 and the strips of the
second contrasting marker can be formed into a pattern of repeating
parallel strips. The strips of the first contrasting marker 116 and
the strips of the second contrasting marker 118 may alternate so
that each strip having the first contrasting marker 116 is adjacent
to at least one strip having the second contrasting marker 118 and
each strip having the second contrasting marker 118 is adjacent to
at least one strip having the first contrasting marker 116. Often,
each strip having the first contrasting marker 116 may be adjacent
to two strips having the second contrasting marker 118, and each
strip having the second contrasting marker 118 may be adjacent to
two strips having the first contrasting markers 116.
[0065] In some embodiments, the tissue interface 208 having the
strips of the first contrasting marker 116 and the second
contrasting marker 118 can be formed by dying the material of the
tissue interface 208. For example, the tissue interface 208 may be
formed into its material shape, and a dye may be applied to form
the pattern of repeating parallel stripes. In other embodiments,
the material of the tissue interface 208 can be dyed in other
patterns. For example, the tissue interface 208 can be dyed with
the first contrasting marker 116 and the second contrasting marker
118 to have geometric patterns, amorphous patterns, spiral
patterns, sunburst patterns, meandering patterns, wave patterns,
foam patterns, tiling patterns, crack patterns, rotational
patterns, and reflective patterns.
[0066] FIG. 3A is a perspective view of another tissue interface
207 illustrating additional details that may be associated with
some embodiments of a manufacturing process for the tissue
interface 208. FIG. 3B is a perspective view of another tissue
interface 209 illustrating additional details that may be
associated with some embodiments of the manufacturing process for
the tissue interface 208. The tissue interface 207 of FIG. 3A may
be similar to and operate as described above with respect to the
tissue interface 208. In some embodiments, the tissue interface 207
can be marked with the first contrasting marker 116. The tissue
interface 209 of FIG. 3B may be similar to and operate as described
above with respect to the tissue interface 208. In some
embodiments, the tissue interface 209 can be marked with the second
contrasting marker 118.
[0067] FIG. 4A is a perspective view of the tissue interface 207,
and FIG. 4B is a perspective view of the tissue interface 209,
illustrating additional details that may be associated with some
embodiments of the manufacturing process for the tissue interface
208. The tissue interface 207 and the tissue interface 209 may be
divided into portions. For example, each of the tissue interface
207 and the tissue interface 209 may be cut, torn, melted, or
otherwise divided to form smaller portions of each of the tissue
interface 207 and the tissue interface 209 having the first
contrasting marker 116 and the second contrasting marker 118,
respectively.
[0068] FIG. 5A is an exploded perspective view of the tissue
interface 207, and FIG. 5B is an exploded perspective view of the
tissue interface 209, illustrating additional details that may be
associated with some embodiments of the manufacturing process for
the tissue interface 208. As shown, the divided portions of the
tissue interface 207 can be separated to form strips 220, 222, 224,
226, and 228 of the tissue interface 207 having the first
contrasting marker 116. Similarly, the divided portions of the
tissue interface 209 can be separated to form strips 221, 223, 225,
227, and 229 of the tissue interface 209 having the second
contrasting marker 118.
[0069] Preferably, the strips 220, 222, 224, 226, and 228 and the
strips 221, 223, 225, 227, and 229 are formed having substantially
similar sizes and shapes. The strips 220, 222, 224, 226, and 228
may each have a top surface 240, a first surface 242, a second
surface 244 opposite the first surface 242, a bottom surface 246
opposite the top surface 240, a first end surface 248, and a second
end surface 250 opposite the first end surface 248. The strips 221,
223, 225, 227, and 229 may each a top surface 241, a first surface
243, a second surface 245 opposite the first surface 243, a bottom
surface 247 opposite the top surface 241, a first end surface 249,
and a second end surface 251 opposite the first end surface 249. In
some embodiments, the strips 220, 222, 224, 226, and 228 may each
have a width 230, and the strips 221, 223, 225, 227, and 229 may
each have a width 232. In some embodiments, the width 230 and the
width 232 may be between about 2 mm and about 20 mm. In other
embodiments, the width 230 of the strips 220, 222, 224, 226, and
228 and the width 232 of the strips 221, 223, 225, 227, and 229 may
be variable from strip to strip.
[0070] FIG. 6 is an exploded perspective view of the tissue
interface 208, illustrating additional details that may be
associated with some embodiments. The tissue interface 208 can be
formed from the strips 220, 222, 224, 226, and 228 of the tissue
interface 207 having the first contrasting marker 116 and the
strips 221, 223, 225, 227, and 229 of the tissue interface 209
having the second contrasting marker 118. To form the tissue
interface 208, the strips 220, 222, 224, 226, and 228 may be
coupled to the strips 221, 223, 225, 227, and 229. For example, the
strip 220 of the tissue interface 207 can be coupled to the strip
221 of the tissue interface 209. In some embodiments, the strip 220
will be coupled to the strip 221 so that the second surface 244 of
the strip 220 contacts and is coupled to the first surface 243 of
the strip 221. Similarly, the first surface 242 of the strip 222
can be coupled to the second surface 245 of the strip 221 so that
the strip 222 is on an opposite side of the strip 221 from the
strip 220. Preferably, the first end surface 248 of the strip 220
can be aligned with the first end surface 249 of the strip 221.
Similarly, the second end surface 250 of the strip 220 may be
aligned with the second end surface 251 of the strip 221; the top
surface 240 can be aligned with the top surface 241; and the bottom
surface 246 can be aligned with the bottom surface 247. The strip
223 can be similarly coupled to the strip 222; the strip 224 can be
similarly coupled to the strip 223; the strip 225 can be coupled to
the strip 224; the strip 226 can be coupled to the strip 225; the
strip 227 can be coupled to the strip 226; the strip 228 can be
coupled to the strip 227; and the strip 229 can be coupled to the
strip 228 to form the tissue interface 208.
[0071] Coupling of the strips 220, 222, 224, 226, and 228 and the
strips 221, 223, 225, 227, and 229 can be performed by welding,
adhesion, bonding, mechanical interlocking, or other coupling
mechanisms, such as magnets disposed in the strips 220, 222, 224,
226, and 228 and the strips 221, 223, 225, 227, and 229. For
example, the strips 220, 222, 224, 226, and 228 and the strips 221,
223, 225, 227, and 229 can be placed in their respective positions
and compressed and heated to fuse contacting surfaces to each
other. In some embodiments, the strips 220, 222, 224, 226, and 228
and the strips 221, 223, 225, 227, and 229 can be compressed using
a force required to compress an exemplary specimen of the material
forming the strips 220, 222, 224, 226, and 228 and the strips 221,
223, 225, 227, and 229 to a height that is about 25% of the
specimen's original height. The compression can occur at a
temperature between about 100 degrees centigrade and about 200
degrees centigrade, although the temperature can vary depending on
the material used for the strips 220, 222, 224, 226, and 228 and
the strips 221, 223, 225, 227, and 229. Welding can also include
radio-frequency (RF) welding, ultrasonic welding, and hot-plate
welding. Adhesion can include application of an adhesive to mating
surfaces of the strips 220, 222, 224, 226, and 228 and the strips
221, 223, 225, 227, and 229. Suitable adhesives can include
polyurethane adhesives, acrylics, elastomeric adhesives,
thermoplastic elastomers, solvent-borne adhesive, water-borne
adhesives, and hot-melt adhesive. Mechanical interlocking can
include the use of dovetail joints or mortise and tenon joints,
hook-and-loop fasteners. After coupling of the strips 220, 222,
224, 226, and 228 and the strips 221, 223, 225, 227, and 229, the
tissue interface 208 can be further shaped as needed for
distribution and use.
[0072] In other embodiments, the strips 220, 222, 224, 226, and 228
and the strips 221, 223, 225, 227, and 229 can be formed into
non-linear, curvilinear, or amorphous portions. For example, the
strips 220, 222, 224, 226, and 228 and the strips 221, 223, 225,
227, and 229 can be formed into interlocking tiles. Each of the
interlocking tiles can be formed such that the surfaces of a strip,
for example, the strip 221 can interlock with the surfaces of a
corresponding strip 220 and vice versa. In this manner, the tissue
interface 208 having non-linear patterns can be constructed by the
process described above.
[0073] In some embodiments, the tissue interface 208 may be
sizeable. For example, at an interface between the strip 220 and
the strip 221, the tissue interface 208 may be separated. In some
embodiments, fusing of the strips 220, 222, 224, 226, and 228 to
the strips 221, 223, 225, 227, and 229 form separation zones in the
tissue interface 208. The separation zones comprise areas of the
tissue interface 208 where portions of the tissue interface 208 may
be preferentially separated from each other. Generally, the fused
surfaces of the strips 220, 222, 224, 226, and 228 and the strips
221, 223, 225, 227, and 229 are weaker than the solid portions of
each of the strips 220, 222, 224, 226, and 228 and the strips 221,
223, 225, 227, and 229. Consequently, the tissue interface 208 may
be separated along the separation zones formed by the interface
between each of the strips 220, 222, 224, 226, and 228 and the
strips 221, 223, 225, 227, and 229 before breaking of the solid
portions of the strips 220, 222, 224, 226, and 228 and the strips
221, 223, 225, 227, and 229.
[0074] In other embodiments, the tissue interface 208 may comprise
two tissue interfaces 208 formed as above and stacked one on top of
the other. The stacked tissue interfaces 208 may be compressed and
fused so that the top surfaces 240, 241 of a lower tissue interface
208 may be coupled to the bottom surfaces 246, 247 of an upper
tissue interface 208. Similar to the coupling of the first surfaces
242 to the second surfaces 245 and the first surfaces 243 to the
second surfaces 244, the coupling of the top surfaces 240, 241 to
the bottom surfaces 246, 247 permit the lower tissue interface 208
to be separated from the upper tissue interface 208 to adjust a
height of the tissue interface 208. During use, the tissue
interfaces 208 may be separable along the contacting surfaces,
permitting the tissue interfaces to be sized for particular depths
of tissue sites.
[0075] FIG. 7 is perspective view of another tissue interface 308
illustrating additional details that may be associated with some
embodiments. The tissue interface 308 may be similar to and operate
as described above with respect to the tissue interface 108. The
tissue interface 308 may include the first contrasting marker 116
and the second contrasting marker 118. In some embodiments, tissue
interface 308 includes a plurality of segments. For example, the
tissue interface 308 includes segments 310, 312, and 314 having the
first contrasting marker 116, and segments 311, 313, and 315 having
the second contrasting marker 118.
[0076] Each segment 310, 312, and 314 and 311, 313, and 315 may
have a top surface, a bottom surface, an interior side surface, and
an exterior side surface. The interior side surface and the
exterior side surface transcribe a spiral having a fixed center
point that continuously increases distance from the fixed center
point. The interior side surface may be a side of a segment facing
toward the fixed center point, and the exterior side surface may be
a side of a segment facing away from the fixed center point. The
interior side surface and the exterior side surface can originate
from the same fixed center point. The interior side surface may
increase at a different rate than the exterior side surface. As a
result, each segment 310, 312, and 314 and 311, 313, and 315
increases in thickness from the fixed center point to an outside
edge of the tissue interface 308.
[0077] The interior surface and the exterior surface of each
segment 310, 312, and 314 and 311, 313, and 315 can be correlated
so that the exterior surface of a first segment can be placed
adjacent to an interior surface of a second segment to form a
larger body. For example, the interior surface of the segment 311
can be positioned adjacent to the exterior surface of the segment
310, and the interior surface of the segment 312 can be positioned
adjacent to the exterior surface of the segment 311. The segments
310, 312, and 314 and 311, 313, and 315 can coupled to each other
to form the tissue interface 308. For example, the exterior
surfaces of segments 310, 312, and 314 can be adhered, welded,
bonded, or otherwise coupled to the interior surfaces of the
segments 311, 313, and 315, respectively. Similarly, the interior
surfaces of segments 312 and 314 can be adhered, welded, bonded, or
otherwise coupled to the exterior surfaces of segments 311 and 313,
respectively. The coupling of segments 310, 312, and 314 to
segments 311, 313, and 315 produces the tissue interface 308 having
a spiral pattern. The spiral pattern exhibits alternating spirals
of the first contrasting marker 116 and the second contrasting
marker 118.
[0078] FIG. 8 is a perspective view of the tissue interface 308
illustrating additional details of the first contrasting marker 116
and the second contrasting marker 118. The tissue interface 308
includes the segments 310, 312, and 314 coupled to the segments
311, 313, and 315. In the illustrated embodiment, the segments 310,
312, and 314 have the first contrasting marker 116, and the first
contrasting marker 116 is yellow. The segments 311, 313, and 315
have the second contrasting marker 118, and the second contrasting
marker 118 is blue, a complementary color to yellow. In some
embodiments, yellow and blue may be the preferred complementary
pairs. For example, the sRGB number for the preferred shade of
yellow is 255, 255, 0, and has a light wavelength of about 570
nanometers; the sRGB for the preferred complementary shade of blue
is 0, 0, 255 and has a light wavelength of about 475
nanometers.
[0079] FIG. 9 is a perspective view of another tissue interface
408, illustrating additional details that may be associated with
some embodiments. The tissue interface 408 includes segments 410,
412, and 414 coupled to segments 411, 413, and 415. In the
illustrated embodiment, the segments 410, 2412, and 414 have the
first contrasting marker 116. The segments 411, 413, and 415 have
the second contrasting marker 118. As shown, the segments 410, 412,
and 414 are coupled to the segments 411, 413, and 415 and form
concentric rings. The segments 410, 412, and 414 and the segments
411, 413, and 415 are coupled to each other so that the segments
410, 412, and 414 having the first contrasting marker 116 alternate
with the segments 411, 413, and 415 having the second contrasting
marker. Each successive segment 410, 412, and 414 and segment 411,
413, and 415, has an inner diameter substantially the same as an
outer diameter of a previous segment 410, 412, and 414 and segment
411, 413, and 415.
[0080] FIG. 10 is a perspective view of another tissue interface
508, illustrating additional details that may be associated with
some embodiments. In some embodiments, the tissue interface 508 may
be a mesh or a woven interface. The mesh or the woven tissue
interface 508 may be woven with differently colored threads or
fibers having the first contrasting marker 116 and the second
contrasting marker 118. For example, the tissue interface 508 may
have a first group of threads 510 and a second group of threads
512. The first group of threads 510 may be dyed with the first
contrasting marker 116, and the second group of threads 512 may be
dyed with the second contrasting marker 118. In some embodiments,
the first group of threads 510 may be woven with the second group
of threads 512 to create shapes or images of brands or trademarks
to permit the first contrasting marker 116 and the second
contrasting marker 118 to provide an indication of source. In some
embodiments, the first contrasting marker 116 and the second
contrasting marker 118 can be printed onto an external surface of
the mesh or woven tissue interface 508. In other embodiments, the
first group of threads 510 and the second group of threads 512 may
be formed into the tissue interface 508 as a non-woven. A non-woven
tissue interface 508 can be formed by melt-blown, spun-blown,
air-laid, scatter coated, or coupled in another non-woven formation
process.
[0081] In some embodiments, the tissue interface 108 may have a
first color when disposed in a tissue site. After a time period in
the tissue site, the tissue interface 108 may have a second color.
In some embodiments, the second color may exhibit a pattern. For
example, the tissue interface 108 may be black when placed into a
tissue site. After approximately 24 hours, the tissue interface 108
may exhibit a pattern similar to the pattern illustrated in FIG. 8.
In other embodiments, the tissue interface 108 may be white, and
after approximately 24 hours may exhibit a pattern similar to the
pattern illustrated in FIG. 8. In some embodiments, the tissue
interface 108 may have a thermochromic pigment disposed in the
tissue interface 108. The thermochromic pigment may react with
heat, such as body heat; fluid, such as body fluid; or a change in
acidity or alkalinity of the environment. For example, the
thermochromic pigment may be disposed in the tissue interface 108
in a pattern similar to that illustrated in FIG. 8. In response to
the heat generated by the tissue site, the thermochromic pigment
may react to change color from the first contrasting marker 116 to
the second contrasting marker 118. Portions of the tissue interface
108 having the thermochromic pigment can then change from the
color, providing a visual contrast in the tissue interface 108.
[0082] FIG. 11 is a schematic depiction of a manufacturing system
for producing a tissue interface, such as the tissue interface 108
of FIG. 1. The tissue interface 108 may be manufactured in a
variety of ways. For example, the tissue interface may be formed
from foam, such as GranuFoam.RTM. available from Kinetic Concepts,
Inc. of San Antonio, Tex. As shown in FIG. 11, the tissue interface
108 may be manufactured in an extrusion process. For example, the
system 600 may include a controller 602, a first supply 604, a
second supply 606, a first extruder 608, and a second extruder 610.
The controller 602 may be communicatively coupled to the first
supply 604, the second supply 606, the first extruder 608, and the
second extruder 610. In some embodiments, the first supply 604 may
be in fluid communication with the first extruder 608, and the
second supply 606 may be in fluid communication with the second
extruder 610.
[0083] Ingredients, such as isocyanates, polyols, and pigments may
be fed to and mixed in the first supply 604 and the second supply
606. In some embodiments, the first supply 604 and the second
supply 606 may include the same or similar ingredients. The first
supply 604 and the second supply 606 may be fed different pigments.
For example, the first supply 604 may receive a pigment
corresponding with the desired color for the first contrasting
marker 116, and the second supply 606 may receive pigment
corresponding with the desired color for the second contrasting
marker 118. The ingredients in the first supply 604 may be fed to
the first extruder 608. There, the ingredients can be mixed, a gas
can be generated or injected into the ingredients, and the mixed
ingredients can expand as they begin to form a polyurethane
polymer. The ingredients in the second supply 606 may be fed to the
second extruder 610. There, the ingredients can be mixed, a gas can
be generated or injected into the ingredients, and the mixed
ingredients can expand as they begin to form a polyurethane
polymer. The polyurethane polymer in the first extruder 608 and the
polyurethane polymer in the second extruder 610 may be extruded
onto a surface, such as a platform or assembly line.
[0084] In some embodiments, the polyurethane polymer in the first
extruder 608 may have the first contrasting marker 116 and the
polyurethane polymer in the second extruder 610 may have the second
contrasting marker 118. The first extruder 608 and the second
extruder 610 may be controlled to provide a stripe pattern similar
to the pattern of the tissue interface 208 of FIG. 2. In other
embodiments, the first extruder 608 and the second extruder 610 may
be controlled to provide a swirl pattern similar to the pattern of
the tissue interface 308 of FIG. 7. The system 600 can produce a
tissue interface, such as the tissue interface 108 having the
contrasting marker 116 and the contrasting marker 118 extending
through the entirety of the tissue interface 108.
[0085] In other embodiments, the tissue interface 108 may be batch
cast. For example, a container may be filled with a liquid polymer.
The liquid polymer may be in a solution form, an emulsion form, or
a solid. The liquid polymer may be in the process of foaming.
Pigments corresponding to the first contrasting marker 116 and the
second contrasting marker 118 may be added to the liquid polymer.
The pigments can be added to form patterns, shapes, or other
ornamental features as the liquid polymer sets into a foam. In
other embodiments, the liquid polymer may foam after the
application of a secondary process, such as heating, exposure to
ultraviolet light, or similar process. The container may also be
filled with the liquid polymer using a co-extrusion process similar
to that described and illustrated with respect to the system 600 of
FIG. 9. In some embodiments, the pigments may be imperfectly mixed
in the liquid polymer to provide a jazzed or marbled effect. The
liquid polymer may then be cured to form the tissue interface 108.
In some embodiments, the tissue interface 108 may be formed from
casting or molding polymers. The process can employ extrusion or
injection processes similar to those described with respect to the
system 600 of FIG. 11. In still other embodiments, the tissue
interface 108 can be printed from feed stock. For example, a tissue
interface 108 may have the first contrasting marker 116 and the
second contrasting marker 118 formed on a surface of the tissue
interface 108 using a printing process.
[0086] The systems, apparatuses, and methods described herein may
provide significant advantages. For example, the tissue interfaces
described herein provide an adaptation that addresses the
long-standing retained material challenge, i.e. material remaining
in the tissue site post removal of the tissue interface. The tissue
interfaces do not require material reformulations, permitting
better identification of the tissue interface in a tissue site
without requiring new material, x-ray technology, or magnetic
scanners. The contrasting markers augment the visibility of the
tissue interface in a tissue site, reducing the likelihood that a
tissue interface or portion of a tissue interface may be left in
the tissue site. The tissue interfaces described herein also
provide additional value to potential users. Specifically, the
performance of the tissue interface is increased over similar wound
fillers without requiring additional equipment or training for the
end user.
[0087] While shown in a few illustrative embodiments, a person
having ordinary skill in the art will recognize that the systems,
apparatuses, and methods described herein are susceptible to
various changes and modifications. Moreover, descriptions of
various alternatives using terms such as "or" do not require mutual
exclusivity unless clearly required by the context, and the
indefinite articles "a" or "an" do not limit the subject to a
single instance unless clearly required by the context. Components
may be also be combined or eliminated in various configurations for
purposes of sale, manufacture, assembly, or use. For example, in
some configurations the dressing 102, the negative-pressure source
104, or both may be eliminated or separated from other components
for manufacture or sale. In other example configurations, the
tissue interface 108 may also be manufactured, configured,
assembled, or sold independently of other components.
[0088] The appended claims set forth novel and inventive aspects of
the subject matter described above, but the claims may also
encompass additional subject matter not specifically recited in
detail. For example, certain features, elements, or aspects may be
omitted from the claims if not necessary to distinguish the novel
and inventive features from what is already known to a person
having ordinary skill in the art. Features, elements, and aspects
described herein may also be combined or replaced by alternative
features serving the same, equivalent, or similar purpose without
departing from the scope of the invention defined by the appended
claims.
* * * * *